Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in sebaceous hyperplasia lesion count
研究概览
简要总结
The purpose of this study is to compare treatment of sebaceous hyperplasia with pulsed dye laser (PDL) plus neodymium doped yttrium aluminum garnet laser (Nd:YAG) versus erbium doped yttrium aluminum garnet (erbium:YAG) laser versus electrodesiccation and curettage (ED&C).
This is a randomized clinical trial. Approximately 18 participants will enrolled. Each participant will have their sebaceous hyperplasia lesions randomized to receive either Erbium:YAG, PDL plus Nd:YAG, or ED&C treatment. Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Lesions will be treated twice, 2-6 weeks after the first treatment. Lesion size and count will be measured before treatment and at follow-up 4-12 weeks after the first treatment. This study is a pilot study designed to determine the feasibility of these procedures.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age
- •Receiving cosmetic treatment for sebaceous hyperplasia
- •In good general health as assessed by the investigator
- •Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
排除标准
- •Patient pregnant or nursing
- •Patient with history of poor wound healing that would result in hypertrophic scar or keloid at the discretion of the physician
- •Patient with recent sun exposure that would result in pigment changes at the discretion of the physician
- •Subject unwilling to sign an IRB approved consent form
- •Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
研究组 & 干预措施
Erbium:YAG Laser
Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.
干预措施: Erbium:YAG Laser (Device)
PDL plus Nd:YAG
Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.
干预措施: Pulsed Dye Laser (Device)
PDL plus Nd:YAG
Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.
干预措施: Nd:YAG Laser (Device)
ED&C treatment
Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.
干预措施: Electrodessication and curettage (Procedure)
结局指标
主要结局
Change in sebaceous hyperplasia lesion count
时间窗: 4-12 weeks
Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment
Change in size of sebaceous hyperplasia
时间窗: 4-12 weeks
Change in size of sebaceous hyperplasia from baseline to 4-12 weeks after first treatment by measuring length and width in mm of each lesion.
次要结局
未报告次要终点
研究者
Murad Alam
Professor of Dermatology
Northwestern University